Core Viewpoint - CloudTop New Horizon (HKEX 1952.HK) announced the approval of its expanded production application for NEFECON (Budesonide Enteric-Coated Capsules), the first and only fully approved IgA nephropathy targeted therapy in China, which will enhance production capacity and meet the growing clinical demand in China and Asia [1][2]. Group 1: Product Approval and Market Impact - NEFECON is the first and only IgA nephropathy targeted therapy fully approved in China, the US, and Europe, establishing it as a cornerstone drug for IgA nephropathy treatment [1][3]. - The approval for expanded production will allow for a more efficient response to the increasing clinical needs of IgA nephropathy patients in Asia, where the disease is highly prevalent [1][2]. - There are over 5 million IgA nephropathy patients in China, with more than 100,000 new cases diagnosed annually, indicating a significant unmet clinical need [1][2]. Group 2: Clinical Efficacy and Guidelines - NEFECON has been shown to reduce the risk of kidney function decline by 50% in global Phase III NefIgArd studies, with a 66% reduction observed in the Chinese population [2][5]. - The drug delays the progression to dialysis or kidney transplantation by an average of 12.8 years, highlighting its clinical significance [2][5]. - NEFECON is the only IgA nephropathy targeted therapy recommended by both international and domestic clinical guidelines, solidifying its position as a first-line treatment [3][5]. Group 3: Mechanism of Action - NEFECON works by specifically modulating intestinal mucosal immunity to reduce the production of Gd-IgA1, which triggers IgA nephropathy, thereby effectively controlling proteinuria and protecting kidney function [2][5]. - The formulation includes a unique triple-layer coating that ensures targeted release of Budesonide to the mucosal B cells in the ileum, enhancing its therapeutic effect [5].
云顶新耀全球首个IgA肾病对因治疗药物耐赋康®扩产获批，扩大患者用药可及